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Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00439738
First received: February 23, 2007
Last updated: February 9, 2009
Last verified: January 2009

February 23, 2007
February 9, 2009
December 2006
November 2007   (final data collection date for primary outcome measure)
Change in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
Change in MSSBP from baseline to Week 8
Complete list of historical versions of study NCT00439738 on ClinicalTrials.gov Archive Site
  • Change in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline to Weeks 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg) [ Time Frame: Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16) ] [ Designated as safety issue: No ]
  • Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg) [ Time Frame: Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16) ] [ Designated as safety issue: No ]
  • Change From Baseline in Postprandial Glucose [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change From Baseline in Postprandial Insulin [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change From Baseline in Postprandial Non-Esterified Fatty Acids [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change in mean sitting diastolic blood pressure (MSDBP) from baseline to Weeks 4, 8, 12 and 16
  • Proportion of patients achieving blood pressure (BP) control at Weeks 4, 8, 12 and 16
  • Change from baseline in postprandial glucose, insulin and non-esterified fatty acids 2 hours after an oral glucose tolerance test at Week 16
  • Evaluate safety and tolerability baseline to Week 16
Not Provided
Not Provided
 
Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults
A 16-Week Double-Blind, Randomized, Multicenter, Force-Titration Study to Evaluate the Antihypertensive Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Therapy Compared to HCTZ Based Therapy in Obese, Hypertensive Patients

The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure [MSSBP] >150 mmHg) patients.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: HCTZ + Amlodipine
    • 12.5 mg HCTZ capsules
    • 25 mg HCTZ capsules
    • 5 mg amlodipine capsules
    • 10 mg amlodipine capsules
  • Drug: Valsartan/HCTZ
    • 160 mg film-coated valsartan tablets
    • 320 mg film-coated valsartan tablets
    • 12.5 mg HCTZ capsules
    • 25 mg HCTZ capsules
  • Experimental: valsartan/HCTZ
    Intervention: Drug: Valsartan/HCTZ
  • Active Comparator: HCTZ +Amlodipine
    Intervention: Drug: HCTZ + Amlodipine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
412
Not Provided
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 40 years of age or older
  • Moderate or severe high blood pressure defined as systolic blood pressure (the top number) greater than or equal to 150 mmHg and diastolic blood pressure (the bottom number) less then 110 mmHg
  • Central (abdominal) obesity

Exclusion Criteria:

  • Systolic blood pressure (the top number) greater than or equal to 180 mmHg and diastolic blood pressure (the bottom number) greater than or equal to 110 mmHg
  • Currently taking more then 3 medications to treat high blood pressure
  • Inability to stop all current blood pressure medications if any up to 4 weeks
  • History of Type 1 or Type 2 diabetes
  • History of stroke, mini-stroke (transient ischemic attack) or heart attack within the last 6 months
  • History of or current diagnosis of congestive heart failure
  • History of cancer within the past 5 years with the exception of localized basal cell carcinoma or squamous cell carcinoma
  • Women who are pregnant or nursing
  • Alcohol or drug abuse within the last 2 years

Other protocol-defined inclusion/exclusion criteria may apply

Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00439738
CVAH631BUS06
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP